Global Regulatory Strategy Director

Bristol Myers Squibb; Needham (MA); On-site; USD 215,000 - 292,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing programs

401(k) & disability insurance

Job summary

Bristol Myers Squibb is seeking a Director, Regulatory Strategist to lead global and US regulatory plans, coordinate with clinical teams, and manage interactions with health authorities to drive successful product registrations.

You will shape regulatory strategies, oversee cross-functional teams, and translate complex scientific data into actionable regulatory filings and risk assessments.

Qualifications

• Proven success in delivering global regulatory strategies in coordination with clinical plans and marketing objectives.
• Excellent communication of strategy, issues, and risks in written and verbal form.
• Experience leading cross-functional matrix teams.
• Ability to break down complex issues and communicate regulatory implications.

Responsibilities

• Develop and lead Global and US Regulatory activities for development teams, leveraging external resources for operations.
• Provide leadership to resolve regulatory project issues and align with HA expectations.
• Create and execute registration strategies for products and translate into operational plans with external vendors.
• Interact strategically with health authorities and shape submission plans for global filings.

Skills

Regulatory strategy

Global regulatory

US regulatory

Cross-functional leadership

HA negotiations

Strategic thinking

Education

Ph.D./MD/PharmD/MS/BS

Job description

Bristol Myers Squibb is seeking a Director, Regulatory Strategist to lead global and US regulatory plans, coordinate with clinical teams, and manage interactions with health authorities to drive successful product registrations.

You will shape regulatory strategies, oversee cross-functional teams, and translate complex scientific data into actionable regulatory filings and risk assessments.